Outset Medical (San Jose, CA) landed FDA clearance for its innovative new hemodialysis designed to expand access to the therapy. The Tablo System was intended to look and operate more like a consumer device so that just about anyone with guided training can learn how to deliver dialysis. Thanks to various automated processes, the number of individual steps the operator has to perform has been reduced by over half compared to existing machines. The large touchscreen display intuitively leads the user through the dialysis process, using animation and step by step instructions.

There’s no need to use distilled water, since the system hooks up to the tap and filters it on its own. It also produces its own dialysis solution, further simplifying the maintenance and operation of the device.

The company is now working toward expanding the FDA indication to include at-home treatment by the patients themselves.

Source:Outset Medical